Study to Identify and Characterize Bacteria Causing Acute Otitis Media in South African Children

NCT ID: NCT01031082

Last Updated: 2010-05-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 265 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-05-31

Brief Summary

The purpose of this study is to identify and characterize the bacteria causing acute otitis media episode in HIV-positive and HIV-negative children (>=3 months to <5 years) in South Africa. Middle ear fluid sampling either by tympanocentesis or by careful sampling of spontaneous otorrhoea will be done; nasopharyngeal aspirate and urine sample will also be collected from the subjects.

Conditions

Acute Otitis Media

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HIV-negative Group

This group is sub-divided into two sub-groups. One sub-group includes HIV-negative/ presumed negative subjects with a new episode of acute otitis media who have not yet received antibiotic therapy for the episode and the other sub-group includes HIV-negative/ presumed negative subjects with treatment failure who have had a diagnosis of acute otitis media and showed no clinical improvement within 48-72 hours of antibiotic treatment.

Middle ear fluid, nasopharyngeal aspirate and urine sample.

Intervention Type: PROCEDURE

Middle ear fluid, nasopharyngeal aspirate and urine sample collection.

HIV-positive Group

This group is sub-divided into two sub-groups. One sub-group includes HIV-positive subjects with a new episode of acute otitis media who have not yet received antibiotic therapy for the episode and the other sub-group includes HIV-positive subjects with treatment failure who have had a diagnosis of acute otitis media and showed no clinical improvement within 48-72 hours of antibiotic treatment.

Middle ear fluid, nasopharyngeal aspirate and urine sample.

Intervention Type: PROCEDURE

Middle ear fluid, nasopharyngeal aspirate and urine sample collection.

Interventions

Middle ear fluid, nasopharyngeal aspirate and urine sample.

Middle ear fluid, nasopharyngeal aspirate and urine sample collection.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age: >= 3 months and < 5 years at the time of enrolment.
• Signs, symptoms, and conditions:
• One of the functional or general signs of otalgia,, conjunctivitis, fever and either
• Paradise's criteria or
• Spontaneous otorrhoea of less than 24 hours.
• Subject will be included as a treatment failure case.
• Written informed consent obtained from parent or guardian prior to study start.

• Documented HIV-positive status as given in subject's medical records. or
• Subjects referred from paediatric HIV clinic.

• Children who have been tested HIV-negative.
• Children whose mothers volunteer to have tested HIV-negative whilst pregnant with the index case and the child is free to any World Health Organization Grade II stigmata of HIV/acquired immunodeficiency syndrome.
• Children who do not fulfil the World Health Organization staging for HIV infection / immunosuppression.

Exclusion Criteria

• Hospitalised during the diagnosis of acute otitis media or during treatment.
• Otitis externa or otitis media with effusion.
• Presence of a transtympanic aerator.
• Systemic antibiotic treatment received for a disease other than acute otitis media in the 72 hours prior to enrolment.
• Receiving antimicrobial prophylaxis for recurrent acute otitis media but excluding cotrimoxazole or isoniazid prophylaxis in HIV exposed children.
• Provision of antibiotic by paediatrician/ENT specialist at the enrolment visit prior to the sampling of the middle ear fluid or spontaneous Otorrhoea.
• Children on antibiotics for acute otitis media who are clinically improving.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

GSK

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Soweto, Gauteng, South Africa

Countries

South Africa

References

Madhi SA, Govender N, Dayal K, Devadiga R, Van Dyke MK, van Niekerk N, Cutland CL, Adrian PV, Nunes MC. Bacterial and Respiratory Viral Interactions in the Etiology of Acute Otitis Media in HIV-infected and HIV-uninfected South African Children. Pediatr Infect Dis J. 2015 Jul;34(7):753-60. doi: 10.1097/INF.0000000000000733.

Reference Type: DERIVED

PMID: 25923426 (View on PubMed)

Other Identifiers

112135

Identifier Type: -

Identifier Source: org_study_id